GLP Compliant CRO Services
GLP or “Good Laboratory Practice” are federal regulations outlined by the FDA, GLP regulations are laid out in 21 CFR parts 11 and part 58. Contract research organizations are considered “GLP compliant” if they have implemented robust quality management systems to ensure the validity, integrity, and reliability of non-clinical safety data submitted for FDA approval.
Emery Pharma’s quality system helps execute, record, maintain, report, and archive data related to non-clinical and environmental safety studies.
Note: It is the responsibility of the Client/Sponsor’s regulatory team to identify critical non-clinical studies that require GLP compliance. Emery Pharma’s Scientists, Quality Assurance (QA), and Regulatory experts are happy to assist in the process.
cGMP Compliant CRO Services
All regulated testing as required for product or material release of pharmaceuticals, excipients, reference standards, etc. are performed at Emery Pharma in compliance to cGMP (Current Good Manufacturing Practices) per 21 CFR Part 210 and 211.
Emery Pharma follows approved standard operating procedures (SOPs), test methods, and protocols to ensure all aspect of our laboratory operations are followed per cGMP. All instruments used for cGMP testing are appropriately qualified and regularly verified for acceptable operation and performance.
These standards are maintained by the audits performed by internal audits, regulatory inspections performed by FDA, as well as external (Client/Sponsor) audits.
Note: The Client/Sponsor bears the responsibility for assessing all testing and validation/verification requirements for their product. Further, the Client/Sponsor is responsible for determining suitability and all regulatory acceptance of their product and/or testing program.
Emery Pharma’s Scientists, Quality Assurance (QA), and Regulatory experts are happy to assist in determining such requirements and conformance to cGMP.